Vice President, Quality Assurance & Regulatory Affairs

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The Vice President of Quality Assurance and Regulatory Affairs (VP, QA/RA) provides leadership and strategic direction for the Company’s Quality Assurance, Quality Control, and Regulatory Affairs functions. The VP, QA/RA is accountable for maintaining a robust and effective quality management system, ensuring regulatory compliance across the Company’s product portfolio and markets, and establishing quality and regulatory strategies that support the Company’s business objectives and continued growth.

This position serves as a member of the senior leadership team and provides strategic guidance on product development, manufacturing, quality, regulatory strategy, risk management, market expansion, and compliance. This is a hands-on executive leadership role in a focused medical device manufacturing environment. The VP, QA/RA will set strategy while remaining actively engaged in complex quality investigations, regulatory decisions, audits, product and manufacturing changes, and team development.

The VP, QA/RA serves as the Company’s senior quality and regulatory authority and primary liaison with the FDA, notified bodies, certification organizations, international regulatory authorities, customers, and other external stakeholders. The role offers the direct impact and visibility of a close-knit operating company with the resources and global reach of the Nihon Kohden organization.

• Provide strategic leadership and overall direction for Quality Assurance, Quality Control, and Regulatory Affairs.
• Establish the vision, priorities, objectives, and operating strategy for the QA/RA organization in alignment with Company’s business and product strategies.
• Lead, develop, and retain a high-performing QA/RA organization, including managers and individual contributors.
• Establish clear accountability, performance expectations, organizational structure, and succession plans within the QA/RA function.
• Coach and develop leaders and employees while promoting a culture of quality, regulatory compliance, accountability, collaboration, and continuous improvement.
• Lead and oversee a QA/RA organization of approximately 25 direct and indirect employees; establish departmental goals, budgets, resource requirements, staffing plans, and performance metrics necessary to support Company objectives.
• Serve as a trusted advisor to the senior leadership team on quality, regulatory, compliance, and product risk matters.
• Provide executive-level recommendations and decision-making support regarding significant quality issues, regulatory risks, product changes, new products, and business opportunities.

• Provide executive ownership and oversight of the Company’s Quality Management System in accordance with FDA QMSR, ISO 13485, and other applicable regulatory and quality requirements.
• Ensure the Quality Management System effectively supports the full product lifecycle, including design and development, manufacturing, supplier management, production, distribution, servicing, and post-market activities.
• Establish and monitor annual quality objectives, key performance indicators, quality metrics, and continuous improvement initiatives.
• Oversee Quality Assurance and Quality Control activities, including design quality, manufacturing quality, receiving inspection, supplier quality, process controls, calibration, and…